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Evaluation Of The Effect of Using an instrument for Organizing Suture threads on Self-efficacy and Satisfaction of Scrub Person

Protocol summary

Study aim
Determining of Evaluation Of The Effect of Using an instrument for Organizing Suture threads on Self-efficacy and Satisfaction of Scrub Person in Operating Room of Alzahra Hospital of Isfahan in 1398-99
Design
A clinical trial with a control group, with a parallel group, one-way, blind, randomized, on 44 staff members of the operating room scrub.
Settings and conduct
This study will be performed on staff in the role of scrub in Al-Zahra Hospital. The sampling method is first available (easy) and then randomly assigned to the control and intervention groups.In the control group,routine method and in the intervention group, an instrument are used for maintenance and arranging surgical sutures . Then, the effect of the independent variable "Using an instrument for Organizing Suture threads " on the dependent variable of "self-efficacy" and "satisfaction" is evaluated. data analyzers are kept blind.
Participants/Inclusion and exclusion criteria
Entry requirements: Training the scrub person to use the tool, working in the fields of general surgery, vascular, neurology, orthopedics, pediatrics, cosmetics, ENT and gynecology, using the method of arranging surgical sutures in at least 3 surgeries and in surgeries that more than 3 surgical sutures have been Opened. No entry conditions: Using a method other than the routine method and other than the tools for organizing surgical sutures
Intervention groups
Control group: Scrub persons who will use the routine method of organizing surgical sutures. The routine method of arranging surgical sutures is to place the surgical sutures after each use, on the surgical table or on a gas to arrange the surgical sutures and make them available. Intervention group: Scrub persons who will use a surgical instrument for organizing Suture threads.
Main outcome variables
In this study, self-efficacy and satisfaction are examined in two groups.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150715023216N7
Registration date: 2020-09-15, 1399/06/25
Registration timing: registered_while_recruiting

Last update: 2020-09-15, 1399/06/25
Update count: 0
Registration date
2020-09-15, 1399/06/25
Registrant information
Name
Said Amini Rarani
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3522 6158
Email address
ghadami@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-24, 1399/06/03
Expected recruitment end date
2020-10-21, 1399/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation Of The Effect of Using an instrument for Organizing Suture threads on Self-efficacy and Satisfaction of Scrub Person
Public title
The Effect of Using an instrument for Organizing Suture threads on Self-efficacy and Satisfaction of Scrub Person
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Participants in the project, including the scrub person in the intervention group, have received the necessary training to use the tool. The scrub person should work in the fields of general , vascular, neurological, orthopedic, pediatric, cosmetic, ENT and gynecology surgery. The scrub person should scrub in surgeries that have more than 3 surgical sutures on the operating table. The scrub person should use the method of organizing surgical sutures in at least 3 surgeries.
Exclusion criteria:
Lack of willingness of the surgical team to continue cooperation in research. Operating room personnel not be present in the operating room during the study for any reason, such as parental leave, etc. Using an other method except the routine method and except the tools of organizing surgical threads for maintaining and arranging surgical threads.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 44
Randomization (investigator's opinion)
Randomized
Randomization description
Prior to the intervention, 44 staff members of Al-Zahra Hospital operating room will enter the study according to their inclusion criteria. These 44 operating room staff will then be assigned random numbers 1 to 44, and they will be randomly assigned (even and odd numbers) in two intervention group (22 people) and control group(22 people). Accidental sampling is done by randomly assigning them to numbers 1 to 44 and placing them in two groups based on even and odd. The control group will use the routine method of organizing surgical sutures. The routine method of arranging surgical sutures is to place the surgical sutures after each use, on the surgical table or on a gas to arrange the surgical sutures and make them available.The intervention group will use the tools to arrange the surgical sutures.
Blinding (investigator's opinion)
Single blinded
Blinding description
The data analyzer is kept blind. After collecting the data in the intervention and control groups, the data was provided to the analyzer and he did not know the type of intervention and the randomization and placement of samples in the groups. .
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Hezar Jerib Street
City
isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۶۵
Approval date
2020-08-05, 1399/05/15
Ethics committee reference number
IR.MUI.RESEARCH.REC.1399.280

Health conditions studied

1

Description of health condition studied
The effect of using surgical instruments
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
In this study, self-efficacy is measured in two groups of operating room personnel in the role of scrub.
Timepoint
Before and after the intervention
Method of measurement
Researcher made a questionnaire

2

Description
In this study, Satisfaction is measured in two groups of operating room personnel in the role of scrub.
Timepoint
after the intervention
Method of measurement
Researcher made a questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The operating room staff is in the role of scrub who use the tools of organizing surgical sutures. After randomization, and placing the samples in the intervention and control groups, the intervention group will use the surgical suture arrangement tool. The test group will be taught how to use the tool. Before and after the intervention, the self-efficacy questionnaire was completed by the experimental group; A questionnaire of satisfaction with the method of arranging surgical sutures will be given to the experimental group after the intervention. Then the data entered by statistical software Spss version 16 will be analyzed using descriptive and analytical tests.
Category
Other

2

Description
Control group: The operating room staff is in the role of scrub who use the routine method to arrange the surgical sutures. The routine method involves holding the surgical sutures on a sterile gauze on the operating table or on the operating table. Before and after the intervention, the self-efficacy questionnaire is completed by the control group. A questionnaire of satisfaction with the method of arranging surgical sutures will be given to the control group after the intervention. Then the data entered by statistical software Spss version 16 will be analyzed using descriptive and analytical tests.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Ahmad Ghadami
Street address
sofe street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 5555
Email
ghadami@nm.mui.ac.ir
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
Hezar jerib street
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 5555
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ahmad Ghadami
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hezar jerib street
City
Isfahan
Province
Isfehan
Postal code
8174673465
Phone
+98 31 3792 7550
Email
ghadami@nm.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ahmad Ghadami
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hezar jerib street
City
Isfahan
Province
Isfehan
Postal code
8174673465
Phone
+98 31 3792 7550
Email
ghadami@nm.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ahmad Ghadami
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hezar jerib street
City
Isfahan
Province
Isfehan
Postal code
8174673465
Phone
+98 31 3792 7550
Email
ghadami@nm.mui.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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